Senior Manager of Quality and Regulatory Affairs

Our client is a pioneering MedTech company based in Paris, developing Class III active implantable devices. With strong clinical adoption, regulatory approvals underway in Europe and the US, and plans for rapid growth, they are entering a new phase of expansion and are looking to hire a Senior Manager of Quality & Regulatory Affairs.

The role

As Senior Manager of Quality & Regulatory Affairs, you will act as second-in-command, helping to lead the company’s quality and regulatory strategy for high-risk Class III active implantable devices. You will oversee an ISO 13485-compliant QMS, manage regulatory submissions and audits, and ensure compliance with EU MDR, FDA regulations, IEC 60601, and IEC 62304. This is a hands-on leadership role with part-ownership of regulatory pathways and quality culture.

Key responsibilities

• Build and maintain an ISO 13485-compliant QMS tailored for Class III active implantable devices.
• Define and execute regulatory strategy for EU MDR and FDA submissions.
• Ensure compliance with 60601 and 62304 standards throughout product development.
• Lead regulatory submissions and act as the primary interface with Notified Bodies and FDA authorities.
• Provide guidance to R&D, clinical, and manufacturing teams on regulatory requirements and design controls.
• Oversee 1–2 direct reports, mentoring and developing the quality and regulatory team.
• Support market entry and global expansion efforts from a regulatory perspective.

Required experience and qualifications

• 10+ years of experience in Quality & Regulatory Affairs for Class III active and/or implantable medical devices.
• Proven expertise with EU MDR, FDA 21 CFR Part 820, 60601, and 62304.
• Demonstrated experience building or scaling ISO 13485-compliant QMS.
• Strong experience managing regulatory submissions and audits for high-risk devices.
• Excellent leadership, communication, and collaboration skills.

Your consultant

As a Recruitment Consultant at Aspire Life Sciences, Taylor Lyons specialises in Quality and Regulatory Affairs recruitment across the MedTech sector in Europe. Taylor works closely with high-growth companies to identify and engage experienced professionals who can drive compliance, innovation, and operational excellence. With a deep understanding of the regulatory landscape and industry demands, Taylor focuses on building long-term partnerships that deliver real impact.